Coupling assembly and polyaxial bone anchoring device comprising the same

ABSTRACT

A coupling assembly for coupling a rod to a bone anchoring element is provided, wherein the coupling assembly includes a receiving part having a first end, a second end, a central axis extending through the first end and second end, an accommodation space for accommodating a head of an anchoring element, a bore extending from the accommodation space to the first end, and a recess for receiving a rod. The accommodation space has an opening at the second end sized to permit insertion of a head of the bone anchoring element. The coupling assembly further includes a retainer element configured to be positioned at least partially in the accommodation space and being radially expandable and/or compressible to allow retaining a head inserted through the opening. The retainer element is held in position adjacent the opening by an engagement structure provided at or in the accommodation space. The coupling assembly further includes a locking element configured to be arranged at least partially in the accommodation space. The locking element is movable from a first position, in which the retainer element is allowed to expand and release an inserted head, to a second position, in which radial expansion of the retainer element is hindered to prevent release of an inserted head. When the locking element is in the second position, a head of an anchoring element can be locked by exertion of a pressure force directly onto the head to press the head against the retainer element.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/818,351, filed Nov. 20, 2017, which is a continuation of U.S. patentapplication Ser. No. 14/964,444, filed Dec. 9, 2015, now U.S. Pat. No.9,848,916, which claims the benefit of U.S. Provisional Application Ser.No. 62/090,242, filed Dec. 10, 2014, the contents of which are herebyincorporated by reference in their entirety, and claims priority fromEuropean Patent Application EP 14 197 226.5, filed Dec. 10, 2014, thecontents of which are hereby incorporated by reference in theirentirety.

BACKGROUND Field

The present disclosure relates to a coupling assembly for coupling a rodto a bone anchoring element and to a polyaxial bone anchoring deviceincluding such a coupling assembly. The coupling assembly includes areceiving part having a channel for receiving the rod, an accommodationspace for accommodating a head of a bone anchoring element, and aretainer element for retaining the head of the bone anchoring element inthe receiving part. The coupling assembly may also include a pressureelement configured to exert a pressure force onto the head of the boneanchoring element. The coupling assembly is configured to receive thehead of the bone anchoring element from a bottom opening of thereceiving part and the retainer element may, for example, snap onto thehead of the bone anchoring element to retain the head in theaccommodation space.

Description of Related Art

Document U.S. Pat. No. 6,248,105 B1 discloses a device for connecting alongitudinal rod with a pedicle screw. The device includes a sleeve, ahollow cylindrical insert, and a spring chuck. The spring chuck hasannular flanges held in a ring-shaped channel near the bottom opening ofthe sleeve. The spring chuck has a cavity designed to receive the headof the pedicle screw. When the rod is locked by means of a tensionscrew, pressure is exerted by the rod onto the insert, which engages thespring chuck by means of respectively complementary conical engagingsurfaces. The spring chuck is thereby crush-locked onto the head of thepedicle screw. The flanges of the spring chuck are received in thering-shaped channel of the sleeve, and thereby the spring chuck is heldin the sleeve and the head is retained in the sleeve.

Document U.S. Pat. No. 6,280,442 B1 discloses a multi-axial bone screwassembly. The assembly includes a receiver member, a crown membermovably disposed in a lower opening portion of the receiver member, anda retaining member. The retaining member defines an aperture smallerthan a width of a head of a bone anchor received therein. The retainingmember is housed in a groove of the receiver member. The groove extendsaround the lower opening portion of the receiver member. The retainingmember prevents removal of the head from the lower opening portion. Theretaining member has a C-shape with a gap allowing the retaining memberto compress to snap into the groove. Once the retaining member isinserted into the groove, the retaining member cannot be furtherexpanded.

Document U.S. Pat. No. 8,556,938 B1 discloses a polyaxial bone screwassembly having a receiver with a lower cavity cooperating with a loweropening. An upper portion of a shank expands a retaining member in thereceiver lower cavity to capture the shank upper portion in thereceiver. Either the retaining member or an insert provides for afriction-fit of the shank upper portion in the receiver. Final lockingof the polyaxial mechanism is provided by frictional engagement betweenthe shank upper portion and the retaining member. A pre-assembledreceiver, retaining member and optional insert may be popped or snappedonto the shank upper portion prior to or after implantation of the shankinto a vertebra.

SUMMARY

It is an object of the present invention to provide a coupling assemblyfor retaining a head of a bone anchoring element to be introduced from abottom opening in the coupling assembly, wherein the reliability anddurability as well as the handling of the assembly is improved.

According to an aspect of the invention, a coupling assembly includes areceiving part, a retainer element, and a locking element. The receivingpart has an accommodation space with an opening at one end of thereceiving part. A head of an anchoring element can be inserted throughthe opening to be received within the accommodation space. The retainerelement is held in position adjacent the opening by an engagementstructure provided at or in the accommodation space.

The retainer element is radially expandable and/or compressible,including when held in position by the engagement structure. Theretainer element may snap over the head of the anchoring element whenthe head is inserted through the opening. In order to retain the head inthe accommodation space of the receiving part, expansion of the retainerelement is prevented or at least hindered by a locking element.According to one embodiment, the locking element partially encompassesan engagement portion of the retainer element in a radial direction tohinder expansion of the retainer element. In a non-locked state, a smallamount of play between respective engagement portions of the retainerelement and the locking element is possible while a release of the headis impeded. As a consequence, the retainer element is prevented fromreleasing the head of the anchoring element.

The locking element is configured to move between a first position inthe accommodation space, wherein the accommodation space permits theretainer element to expand, and a second position, where the abovedescribed radial locking of the retainer element takes place. In thesecond position, when the head of the anchoring element is locked in afinal state, a pressure force oriented towards the bottom opening andexerted directly onto the head presses the head against the retainerelement. The pressure force is exerted directly onto the head by anelement other than the retainer element (for example by the rod and/orthe locking element). In other words, the head is locked between the rodand the retainer element, or between the locking element (as a pressureelement) and the retainer element, or between all three of theseelements.

In the state of final locking, the locking element continues to impederadial expansion of the retainer element and the retainer element isfirmly held in position in the accommodation space of the receiving partby virtue of the engagement structure. In one non-limiting exampleembodiment, the engagement structure holding the retainer element is anannular groove formed in the accommodation space, allowing for expansionof the retainer element when the locking element is in the firstposition. The head of the anchoring element may be inserted into theopening of the accommodation space.

The retainer element is supported by the engagement structure in theaccommodation space of the receiving part as well as by radialengagement of the locking element. Because the retainer element does nottake part in exerting a pressure force from the rod or another element(such as a pressure element) onto the head, the function of the retainerelement is limited to retaining the head of the anchoring element in thecoupling assembly. Accordingly, the reliability and durability of theretainer element is enhanced.

Further, the retainer element does not need to fully encompass the headof the anchoring element, unlike in above described document U.S. Pat.No. 6,248,105 B1. As result, the size of the retainer element,particularly in the direction along the central axis of the receivingpart (as seen when being held in position), is considerably reduced. Assuch, the retainer element may be loaded into the accommodation spacefrom a top direction opposite the opening of the accommodation space.Hence, in situ assembly of the parts is improved and the width of thebottom opening may be narrowed to almost the diameter of the head. As aconsequence, the stability, reliability and durability of the retainerelement is further increased, and dimensions of the receiving part maybe reduced.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be better understood from the description of variousembodiments taken in conjunction with the accompanying drawings. In thedrawings:

FIG. 1 shows a perspective exploded view of a first embodiment of apolyaxial bone anchoring device;

FIG. 2 shows a perspective view of the bone anchoring device of FIG. 1in an assembled state;

FIG. 3 shows a cross-sectional view of the bone anchoring device ofFIGS. 1 and 2;

FIG. 4A shows a cross-sectional view of a receiving part according tothe first embodiment, the cross-section taken along a line AA in FIG.4B;

FIG. 4B shows a top view of the receiving part of FIG. 4A;

FIG. 5A shows a perspective view from above the receiving part shown inFIG. 4A;

FIG. 5B shows a perspective view from below the receiving part shown inFIG. 4A;

FIG. 6A shows a perspective view from above a locking element accordingto the first embodiment;

FIG. 6B shows a perspective view from below the locking element of FIG.6A;

FIG. 7A shows a cross-sectional view of the locking element shown inFIG. 6A, the cross-section taken along a line BB in FIG. 7B;

FIG. 7B shows a top view of the locking element of FIG. 6A;

FIG. 8A shows a perspective view from above a retainer element accordingto the first embodiment;

FIG. 8B shows a perspective view from below the retainer element of FIG.8A;

FIG. 9A shows a cross-sectional view of the retainer element of FIG. 8A,the cross-section taken along line DD in FIG. 9B;

FIG. 9B shows a top view of the retainer element of FIG. 8A;

FIG. 10A shows a cross-sectional view of a first step of inserting aretainer element into a receiving part according to the firstembodiment;

FIG. 10B shows a cross-sectional view of a second step of inserting theretainer element into the receiving part according to the firstembodiment;

FIG. 10C shows a cross-sectional view of a third step of inserting theretainer element into the receiving part according to the firstembodiment;

FIG. 10D shows a cross-sectional view of a state in which the retainerelement is held in position by an engagement structure of the receivingpart according to the first embodiment;

FIG. 11A shows a perspective view of a first step of inserting a lockingelement into the receiving part according to the first embodiment;

FIG. 11B shows a perspective view of a second step of inserting thelocking element into the receiving part according to the firstembodiment;

FIG. 11C shows a perspective view of a third step of inserting thelocking element into the receiving part according to the firstembodiment;

FIG. 12A shows a cross-sectional view of a state of the couplingassembly wherein the locking element is in a first position according tothe first embodiment;

FIG. 12B shows a cross-sectional view of a state of the couplingassembly wherein a head of an anchoring element is inserted into anopening of coupling assembly according to the first embodiment;

FIG. 12C shows a cross-sectional view of a state of the couplingassembly wherein the retainer element is expanded by the head of ananchoring element according to the first embodiment;

FIG. 12D shows a cross-sectional view of a state of the couplingassembly wherein insertion of the head of the bone anchoring element iscompleted, the head is received by a hollow spherical segment-shapedrecess portion of the retainer element and the locking element continuesto be in the first position, according to the first embodiment;

FIG. 13A shows a step of locking the retainer element and simultaneouslypre-locking the head of the anchoring element with a friction-fitaccording to the first embodiment;

FIG. 13B shows a step of inserting a rod into the polyaxial boneanchoring device according to the first embodiment;

FIG. 13C shows a step of tightening a fixation element and final lockingof the head of the anchoring element at a selected orientation withpressure forces exerted, according to the first embodiment;

FIG. 14 shows a perspective exploded view of a second embodiment of apolyaxial bone anchoring device;

FIG. 15 shows a perspective view of the bone anchoring device of FIG. 14in an assembled state;

FIG. 16 shows a cross-sectional view of the bone anchoring device in anassembled state according to the second embodiment;

FIG. 17 shows a perspective view of a bone anchoring element employed inconjunction with the second embodiment;

FIG. 18A shows a perspective view from above the locking element of FIG.14 according to the second embodiment;

FIG. 18B shows a perspective view from below the locking element of FIG.18A;

FIG. 19A shows a cross-sectional view of the locking element of FIG.18A, the cross-section taken along a line EE in FIG. 19B;

FIG. 19B shows a top view of the locking element of FIG. 18A;

FIG. 20A shows a cross-sectional view of a state of the couplingassembly wherein the locking element is in a first position according tothe second embodiment;

FIG. 20B shows a cross-sectional view of a state of the couplingassembly wherein insertion of the head of the bone anchoring element iscompleted, the head is received by a hollow spherical segment-shapedrecess portion of the retainer element, and the locking elementcontinues to be in the first position, according to the secondembodiment;

FIG. 20C shows a state in which the retainer element is locked by thelocking element to retain the head within the accommodation spaceaccording to the second embodiment; and

FIG. 20D shows a step of tightening a fixation element and locking ofthe head of the anchoring element at a selected orientation withpressure forces exerted, according to the second embodiment.

DETAILED DESCRIPTION

A first embodiment of a coupling assembly and a polyaxial bone anchoringdevice is explained with reference to FIGS. 1-13C. FIGS. 1-3 provide anoverview of the assembly and device and FIGS. 4A-9B provide details ofthe assembly and device. FIGS. 10A-13C illustrate the use of theassembly and device according to the first embodiment.

As shown in FIG. 1, a polyaxial bone anchoring device includes ananchoring element 1, a coupling assembly 4, and a fixation element 9,such as a set screw, for connecting a rod 100 with the anchoring element1. The anchoring element 1 has a spherically segment-shaped head 3having a flat top portion 32, an engagement portion 31 for engagement byan external tool such as a driver, and a spherical portion 33. Theanchoring element 1 further has a shank 2 provided with a bone thread 21and a neck portion 22 connecting the shank 2 to the head 3.

The coupling assembly 4 includes a receiving part 5, a retainer element6, a locking element 7, and a pin 8. The receiving part 5 has asubstantially cylindrical shape with optionally flat sides andengagement portions for engagement by an external tool. The receivingpart 5 has a top end 5 a, a bottom end 5 b, and an inner bore 51extending from the top end 5 a in a direction towards the bottom end 5 bas shown in FIG. 4A. As can be seen in more detail in FIGS. 3-5B, anopening 55 is formed at the bottom end 5 b that permits introduction ofa head 3 into an accommodation space 54. The accommodation space 54extends from the opening 55 towards the bore 51 in the receiving part 5.

In this embodiment, the accommodation space 54 has a cylindrical shapeand has an annularly extending groove at the bottom end of theaccommodation space 54 adjacent to the opening 55. The annularlyextending groove functions as an engagement structure 56 for theretainer element 6 and is arranged to receive an annularly shapedengagement portion of the retainer element 6, described below. The bore51, the accommodation space 54, and the annular engagement structure 56are symmetric and coaxial with respect to a central axis C of thereceiving part 5.

As shown in FIGS. 1, 4A, and 5A, a U-shaped recess 52 extends from thetop end 5 a of the receiving part 5 defining two free legs 58. Threads53 are provided at an inner side of the legs 58 facing the inner bore51. A fixation element 9 is provided having an engagement portion 92 foran external tool such as a driver (not shown) and an external thread 91to be threaded into the threads 53 of the receiving part 5. The fixationelement 9 will tighten, fixate and lock a rod 100 in the recess 52 ofthe receiving part 5, as well as the head 3 of the anchoring element 1when inserted into the accommodation space 54.

The locking element 7 is explained in more detail with reference toFIGS. 6A-7B. The locking element 7 has two outer cylindrical surfaceportions 71 arranged opposite with respect to each other. Bothcylindrical surface portions 71 define an outer diameter of the lockingelement 7 substantially corresponding to an inner diameter of theaccommodation space 54 of the receiving part 5. Consequently, when thelocking element 7 is provided in the accommodation space 54, the lockingelement 7 is in sliding engagement with the inner walls of theaccommodation space 54 and is translationally movable along the centralaxis C. Further, a circumference of locking element 7 includes twoopposite recessed outer cylindrical surface portions 79 having a reduceddiameter relative to the outer cylindrical surface portions 71. Therecessed outer cylindrical surface portions 79 are located transverse tothe cylindrical surface portions 71. Both recessed outer cylindricalsurface portions 79 extend respectively between the outer cylindricalsurface portions 71. The reduced diameter of the recessed outercylindrical surface portions 79 is selected to be less than an innerdiameter of the inner bore 51, and may be less than an inner diameter ofthe threads 53, to allow introduction of the locking element 7 into thereceiving part 5 from the top end 5 a in a posture rotated by 90 degreesas compared with the finally assembled state, as shown, for example, inFIGS. 11A-C.

The locking element 7 further has on its top face a rod-receivingportion 75, which is arranged to receive the rod 100 as shown in FIGS. 1and 2. Further, an inner coaxial bore provides access to an inner cavity72 of the locking element 7, which has a spherical segment-shaped recess74 in an upper portion for receiving the partially spherical head 3 anda recess 73 in a bottom portion having a substantially cylindrical innerwall 73 a. Inner wall 73 a may also have a conical or otherwise taperedshape. The recess 73 is adapted to receive a corresponding cylindrical,conical or tapered, etc. engagement portion 62 (“second engagementportion”) of the retainer element 6 to be described below.

The spherical segment-shaped recess 74 of the locking element 7 is sizedand adapted to the spherical portion 33 of the head 3 to allow selectinga specific polyaxial orientation (e.g., an angular orientation) of theanchoring element 1 relative to the receiving part 5 in a pre-lockedstate or in a finally locked state, described below. To establish apre-locked state in this embodiment, two arms 76 are provided in a topportion of the locking element 7. The ends of the arms 76 are providedwith engagement shoulders 77. As shown in FIGS. 3 and 13A, theengagement shoulders 77 may resiliently engage with correspondingengagement shoulders 57 of the receiving part 5, which are provided in awall portion of the inner bore 51, for example, near the bottom end ofthe threads 53. The length of the arms 76 of the locking element 7 andthe vertical positions of the engagement shoulders 57 at the inner wallof the bore 51 of the receiving part 5 are selected such that when theshoulders 57, 77 snap-in and mutually engage with each other, the secondengagement portion 62 of the retainer element 6 is at least partiallyreceived in the recess 73 having the inner wall 73 a as shown in FIG.13A. In such a state, the retainer element 6 is locked and the head 3 isprevented from being released from the retainer element 6, which isdenoted herein as a pre-locked state.

As can be seen from FIGS. 3 and 13A-C, when the rod 100 is received bythe rod-receiving portion 75 of locking element 7, exertion of apressure force on the rod 100 by a fixation element 9 will lead to atransfer of the pressure force onto the locking element 7. The lockingelement 7 transfers the pressure force via its inner sphericalsegment-shaped recess 74 onto the head 3 of anchoring element 1. Assuch, the locking element 7 of the first embodiment functions as apressure element.

Details of the retainer element 6 are explained with reference to FIGS.8A-9B. The retainer element 6 is substantially ring-shaped with a slit63. The retainer element 6 thus represents an open ring. The slit 63allows the retainer element 6 to be radially expanded and/or compressed.The retainer element 6 includes a (“first”) substantially annularengagement portion 61 configured to be received by the annularengagement groove of the engagement structure 56 of the receiving part5, provided at the accommodation space 54 as shown in FIG. 10D. Theretainer element 6 also includes the second engagement portion 62, whichin this embodiment has a slightly conical outer appearance, but may alsobe cylindrical or otherwise tapered. The second engagement portion 62has a plurality of regularly arranged flanges or lugs 65 separated byU-shaped slots to yield a crown-like arrangement. The invention is notlimited to the specific arrangement shown herein. Other kinds ofprojections are possible or a single conical, cylindrical, rounded ortapered wall is possible as well. As shown in FIG. 13A, the secondengagement portion 62 is configured to be received by the recess 73 oflocking element 7, which may have a cylindrical, conical, tapered orrounded inner wall 73 a. Once received in the recess 73 of lockingelement 7, the second engagement portion 62 is prevented from furtherexpansion by abutting against the inner wall 73 a. In this embodiment,the second engagement portion 62 extends from the first engagementportion 61 towards the top end 5 a of the receiving part 5, when beinginserted therein. The first and second engagement portions 61, 62 areformed as a monolithic, single piece.

While the outer appearance of the second engagement portion 62 may becylindrical, conical, tapered or rounded etc., an inner wall of theretainer element 6 includes a hollow spherical segment-shaped portion 64as can particularly be seen in FIG. 9A. A curvature of the sphericalsegment-shaped portion 64 corresponds to that of spherical portion 33 ofhead 3 of anchoring element 1. In other words, spherical segment-shapedportion 64 is arranged to receive and retain the head 3 of anchoringelement 1.

When the second engagement portion 62 of the retainer element 5 isreceived in the recess 73 of the locking element 7, a locked state ofthe retainer element 6 retains the head 3 of anchoring element 1. Insuch a state, the inner diameter of the retainer element 6 is less thanthat of the head 3 to prevent release of the head 3 from retainerelement 6 (which may also be a compressed state of the retainer element6).

The assembly and use of the coupling assembly 4 according to the firstembodiment is explained with reference to FIGS. 10A-13C.

The insertion of the retainer element 6 into the receiving part 5 isexplained with reference to FIGS. 10A-10D. As can be seen in FIG. 10A,the retainer element 6 is inserted into the bore 51 of the receivingpart 5 from a top end 5 a of the receiving part 5. Since an outerdiameter of the retainer element 6 is larger than an inner diameter ofthe bore 51, in particular of the inner threads 53, the retainer element6 is inserted in an inclined or tilted angle relative to the annularengagement structure 56 of the receiving part 5. The retainer element 6is then rotated or tilted towards a horizontal posture when the retainerelement 6 reaches its predetermined position in the accommodation space54. As can be seen in FIGS. 10B and 10C, once the retainer element 6 hasreached the accommodation space 54 having a larger inner diameter ascompared with the bore 51, the retainer element 6 can be brought into aposition less inclined and closer to a coaxial orientation with respectto central axis C.

In an unstressed, unbiased state of the retainer element 6, an outerdiameter of the annular engagement portion 61 is larger than an innerdiameter of the accommodation space 54 such that the retainer element 6abuts an inner wall of the accommodation space 54 when the retainerelement 6 is inserted into the accommodation space 54. The outerdiameter of the retainer element 6 is selected to permit the retainerelement 6 to be held in a coaxial position with the central axis C whenthe annular engagement portion 61 of the retainer element 6 enters andsnaps into the annular engagement groove of the engagement structure 56of the receiving part 5, as depicted in FIG. 10D. The retainer element 6is slightly compressed from the unstressed state until it snaps into thegroove of the engagement structure 56, where the retainer element 6expands again into the unstressed state. The groove of the engagementstructure 56 has a larger inner diameter than the outer diameter of theannular engagement portion 61 of the retainer element 6 in theunstressed state. The diameter of the groove of the engagement structure56 provides enough tolerance, or play, to allow expansion of theretainer element 6 from the unstressed state when the head 3 ofanchoring element 1 is inserted, as described below.

Insertion of the locking element 7 into the receiving part 5 isexplained with reference to FIGS. 11A-11C. As shown in FIG. 11A, thelocking element 7 is introduced into the bore 51 of the receiving part 5from the top end 5 a. Thereby, the protruding outer cylindrical surfaceportions 71 of the locking element 7 face towards the U-shaped recesses52 of the receiving part 5, i.e., the orientation of the locking element7 with respect to its final installed state is offset by 90 degrees.Further, the recessed outer cylindrical surface portions 79 of thelocking element 7 face the threads 53 of the receiving part 5 to allowsafe passage of the locking element 7 within bore 51 and past threads53.

As shown in FIG. 11B, when the locking element 7 (more specifically, itsbottom or base portion including outer cylindrical surface portions 71,79) has passed the inner threads 53 and reached the accommodation space54 of the receiving part 5, the locking element 7 may be rotated by 90degrees by sliding engagement between the outer cylindrical surfaceportions 71 with the inner wall portions of the accommodation space 54.

As shown in FIG. 11C, the locking element 7 is then rotated by 90degrees into its final position with the arms 76 and shoulders 77oriented towards the legs 58 having the threads 53 and engagementshoulders 57, to prepare for engagement of engagement shoulders 57 and77 to establish the pre-locked state explained below with respect toFIG. 13A. In the state shown in FIG. 12A, the protrusions of the arms76, which bear the shoulders 77, rest upon corresponding protrusions atthe inner wall of the bore 51 of the receiving part 5. The bore 51provides the engagement shoulders 57, which face down towards theopening 55 and bottom end 5 b (see FIGS. 3 and 4A). In other words,shoulders 57, 77 are not yet engaged.

FIGS. 12A-12D depict the process of inserting the head 3 of theanchoring element 1 in the accommodation space 54 of the receiving part5. As shown in FIG. 12A, prior to insertion of the head 3, a pin 8 isinserted into an elongate hole 59 formed in a side wall of the receivingpart 5. A tip portion of the pin 8 protrudes into the bore 51 of thereceiving part 5 and into an elongated aperture 761 formed in the arms76 of the locking element 7. In this state, the locking element 7 isprevented from unintended rotation back into the position in which thelocking element 7 was inserted into the receiving part 5 (i.e., a 90degree rotation).

Next, as shown in FIG. 12B, the head 3 of the anchoring element 1 isintroduced into the opening 55 whereby the spherical portion 33 of thehead 3 contacts an inner wall of the retainer element 6. Since theflange-like first engagement portion 61 of the retainer element 6 isfirmly received in the engagement groove of the engagement structure 56of the receiving part 5, the retainer element 6 is held in a coaxialposition with the central axis C. In this position, no translation alongthe central axis C is possible, and the retainer element 6 starts toexpand in a radial direction responsive to further insertion of the head3, which locally increases in diameter as shown by the arrows in FIG.12C. The radial play or tolerance in the engagement structure 56relative to the outer diameter of the retainer element 6 in theunstressed state is thereby the same as or even larger than a differencebetween the maximum outer diameter of head 3 and the minimum innerdiameter of retainer element 6 in the unstressed state, i.e., equal toor larger than the amount of expansion.

As shown in FIG. 12D, further insertion of the head 3 allows theretainer element 6 to return into an unstressed or at least a lessexpanded state. The retainer element 6 along with the receiving part 5snaps onto the head 3 by virtue of the compressive force of the retainerelement 6. FIG. 12D shows that the locking element 7 is still in anunlocked “first” position with respect to the retainer element 6.Nevertheless, since in this state, the spherical head 3 is now receivedand mated with the inner spherical segment-shaped surface 64 of theretainer element 6, a sufficient amount of friction is generatedtherebetween to maintain an angular orientation of the anchoring element1 as desired with respect to the receiving part 5 during assembly andduring in-situ applications prior to final locking. As a consequence, afriction-fit connection between the head 3 and the retainer element 6 isachieved.

Steps of pre-locking and final locking of the head 3 of the anchoringelement 1 as well as locking of the retainer element 6 is explained withreference to FIGS. 13A-13C. As shown in FIG. 13A, locking of theretainer element 6 and pre-locking of the head 3 of the anchoringelement 1 is accomplished by moving the locking element 7 from the firstposition (shown in FIG. 12D) to a second position. In the secondposition, the second engagement portion 62 of the retainer element 6 isreceived in recess 73 and/or cavity 72 of the locking element 7 suchthat an outer surface of the second engagement portion 62 is radiallyengaged from the outside by the inner wall 73 a, and the retainerelement 6 is hindered from further expansion. However, some play betweenthe inner wall 73 a and the second engagement portion 62 is permitted aslong as the head 3 is prevented from being released. In this state, theretainer element 6 is locked and the head 3 cannot be released from theaccommodation space 54 or from the opening 55.

In a next step shown in FIG. 13B, the rod 100 is inserted into theU-shaped recess 52 and received by the rod receiving surface 75 of thelocking element 7. A compressive force exerted by the locking element 7onto the second engagement portion 62 of the retainer element 6 isgenerated when forces trying to remove the anchoring element 1 out ofthe opening 55 are generated.

FIGS. 13A and 13B also show a pre-locked state of the head 3 in thereceiving part 5. In conjunction with the locking of the retainerelement 6 due to the sliding movement of the locking element 7 towardsthe opening 55 and bottom end 5 b along the central axis C, the arms 76of the locking element 7 flex inwards and the shoulders 77 provided atthe tips of arms 76 of the locking element 7 latch resiliently intocorresponding recesses providing the shoulders 57 at the inner wall ofthe inner bore 51 of the receiving part 5. In this state, see FIG. 13A,the retainer element 6 is prevented from expanding beyond the innerwalls 73 a such that the head 3 cannot be released any more from theretainer element 6 (“pre-lock”). At the same time, the above describedfriction-fit connection between the head 3 and the retainer element 6 ismaintained.

FIG. 13C shows the steps of final locking of the head 3 in the receivingpart 5. The fixation element 9 is screwed into the thread 53 of thereceiving part 5 and exerts a downward pressure force onto the rod 100.The rod 100 transfers this pressure force onto the rod receiving portion75 of the locking element 7, which exerts a pressure force on the head 3thereby pressing the head 3 against the hollow spherical segment-shapedportion 64 of the retainer element 6. The retainer element 6 cannotexpand because the retainer element 6 is locked by the locking element7. The retainer element 6 also cannot slide down towards the opening 55and bottom end 5 b because the engagement portion 61 is received in theengagement structure 56. The direction of pressure forces exerted areindicated by arrows in FIG. 13C.

Because the retainer element 6 is dimensioned and shaped to allowinsertion into the receiving part 5 from the top end 5 a as shown inFIGS. 10A-10D, the bottom opening 55 of the receiving part 5 may have asmaller diameter than the retainer element 6, which further supports theretainer element 6 in the engagement structure 56 adjacent the opening55. The further support of the retainer element 6 is made possible byexerting pressure forces directly onto the head 3 via the lockingelement 7 instead of the retainer element 6, as would be suggested bythe spring chuck in above described document U.S. Pat. No. 6,248,105 B1.As compared with the spring chuck, the retainer element 6 is limited infunction to retaining the head 3. As such, the dimensions of theretainer element 6 along the central axis C (i.e., the height of theretainer element 6) may be selected to be shorter allowing introductionof the retainer element 6 into the receiving part 5 from the top end 5a, which permits selecting a smaller width for the bottom opening 55.

A second embodiment of the present invention is explained with respectto FIGS. 14-20D. Like parts as in the first embodiment are referencedwith the same numerals, and description thereof will not be repeatedherein. The second embodiment differs from the first embodiment mainlywith regard to the locking element 7′ and the anchoring element 1′, andto some extent with respect to the receiving part 5′. More specifically,the second embodiment does not provide for a pre-locked state, and thelocking element 7′ is not arranged as a pressure element. However,features of the retainer element 6 and the interaction with the lockingelement 7′ as well as with the engagement structure are the same betweenboth embodiments.

As shown in FIGS. 14-16, the coupling assembly 4′ includes a receivingpart 5′, the retainer element 6, and a locking element 7′. The receivingpart 5′ differs from the receiving part 5 of the first embodiment inthat bore hole 59 is not provided. A bore hole 59 would allowintroducing a pin 8 to lock the locking element 7′ in a pre-lockposition. Instead, a crimp bore 591 is formed in a side wall of thereceiving part 5′.

The locking element 7′ of the second embodiment differs from the lockingelement 7 of the first embodiment in that arms 76 or shoulders 77 arenot provided, which in the first embodiment, facilitate a pre-lockedstate with a friction-fit between the locking element 7 (pressureelement) and the head 3. Instead, the locking element 7′ of the secondembodiment solely serves to lock the retainer element 6 to preventrelease of the head 3′ from the receiving part 5′. As shown in FIGS.18A-19B, a small recess 791 is formed in the protruding outercylindrical surface 71 of the locking element 7′. The recess 791 isconfigured to receive a deformable portion at the end wall of the crimpbore 591 when the deformable portion is deformed to project into theaccommodation space 54 of the receiving part 5′ using an external tool(not shown).

As shown in FIGS. 18A-19B, the locking element 7′ has a substantiallycylindrical shape with protruding outer cylindrical surface portions 71and outer recessed cylindrical surface portions 79 as in the firstembodiment. However, locking element 7′ does not have an inner sphericalsegment-shaped recess. Instead, the locking element 7′ has an inner bore72′ allowing access to an engagement portion 31′ of anchoring element 1′(see FIG. 17). The locking element 7′ also has the recess 73 havinginner wall 73 a as in the first embodiment, which functions to engagethe second engagement portion 62 of the retainer element 6 to lockexpansion of the retainer element 6. The recess 73 is dimensioned andshaped similar to the first embodiment.

The locking element 7′ of the second embodiment does not interact withthe head 3′ of anchoring element 1. Instead, as shown in FIG. 16, therod 100 directly exerts a pressure force onto the head 3′ of theanchoring element 1′.

The anchoring element 1′ according to the second embodiment is shown inFIG. 17. The bone anchoring element 1′ includes a spherical head 3′ thathas a spherical outer surface, including at the free upper end. The head3′ is wholly spherical. An engagement portion 31′ provided at the freeend includes wings 34 that extend in a spiral-like manner from a centerpoint of the upper free end. In this embodiment, the engagement portionhas four wings 34. The four wings 34 describe an outer contour of across with arms bent in the same direction. As such, the engagementsurface of a driver is enhanced compared to usual polygon or otherrecesses, allowing for higher loads to be transferred to the head 3′ byan external driver. Engagement portions for drivers and correspondingtools with a similar shape are known under the trademark Mortorq®. Dueto the spherical contour of the head 3′, the head 3′ may extend throughthe recess 73 and the inner bore 72′ such that a direct pressuretransfer between the rod 100 and the head 3′ can be established.

Assembly and use of the coupling assembly 4′ and polyaxial boneanchoring device including the same according to the second embodimentis explained with respect to FIGS. 20A-D.

As shown in FIG. 20A, which corresponds to the state depicted in FIG.12A regarding the first embodiment, prior to insertion of the head 3′,the locking element 7′ is introduced into the bore 71 of the receivingpart 5′ in a similar manner as shown in FIGS. 11A-C. Thereby, the rodreceiving surface 75′ is aligned with the rod receiving channel orU-shaped recess 52 of the receiving part 5′. The retainer element 6 isheld in position by the groove of the engagement structure 56, whichreceived the first engagement portion 61 of the retainer element 6.

Next, as shown in FIG. 20B, which corresponds to the state depicted inFIG. 12D with regard to the first embodiment, the head 3′ has beeninserted into the bottom opening 55 of receiving part 5′ and received bythe inner hollow spherical segment-shaped portion 64 of the retainerelement 6. In FIGS. 20A and 20B, the locking element 7′ is in the firstunlocked position. The locking element 7′ may be held in this temporaryposition by deforming a deformable portion at an end wall of crimp bore591. The deformable portion then projects from an inner wall of theaccommodation space 54 and into small recess 791 of locking element 7′.

As shown in FIG. 20C, which corresponds to the state depicted in FIG.13A with regard to the first embodiment, the locking element 7′ is movedalong the central axis C in sliding engagement between the cylindricalsurface portions 71 and an inner wall of the accommodation space 54towards the opening 55 and the bottom end 5 b. The inner wall 73 a ofthe cavity 73 is guided onto the second engagement portion 62 of theretainer element 6 to lock the retainer element 6. The comparativelysmall force exerted to move the locking element 7′ may be achievedmanually, e.g., by a tool, or by inserting the rod 100 with a smallpressure force. As in the first embodiment, the locking element 7′hinders further expansion of the retainer element 6 when the secondengagement portion 62 abuts against the inner wall 73 a of the lockingelement 7′.

Because the locking element 7′ does not have a spherical segment-shapedrecess, the inner bore 72′ may be shaped such that there is no or almostno contact between the locking element 7′ and the head 3′ of theanchoring element 1′ when the head 3′ is received in the hollowspherical segment-shaped recess 64 of the retainer element 6.

As shown in FIG. 20D, which corresponds to the state depicted in FIG.13C with regard to the first embodiment, final locking is accomplishedby attaching and tightening the fixation element 9 at the top end 5 a ofthe receiving part 5′, thereby exerting a pressure force onto the rod100 received in the rod receiving portion 75′ of the locking element 7′.The rod 100 transfers the pressure force onto the spherical head 3′. Thespherical head 3′ is adversely pressed against the retainer element 6,which may neither expand nor release the head 3 because the secondengagement portion 62 is radially bound by the inner wall 73 a of thecavity 73. Nor may the retainer element 6 axially move further towardsthe opening 55 because the first engagement portion 61 is received inthe annular groove of the engagement structure 56.

The bone anchoring device of the first and second embodiments as a wholeor in parts may be made of a bio-compatible material, such as abio-compatible metal or a metal alloy, for example titanium, stainlesssteel, a nickel-titanium alloy, for example nitinol, or ofbio-compatible plastic materials, such as, for example,polyetheretherketon (PEEK) or of a bio-compatible ceramic material. Inparticular, the retainer and/or locking elements may be made of asuperelastic nickel-titanium alloy or of beta titanium.

Further modifications of the coupling assembly and polyaxial boneanchoring device may be contemplated.

Other possible modifications of the receiving part may include, forexample, instead of the U-shaped recess being perpendicular to thecentral axis, a recess for the rod may be inclined, open to the side, orin the form of a closed channel. Other kinds of locking devicesincluding outer nuts, outer caps, bayonet locking devices, and othersare also possible as noted above. In particular, a two-part lockingdevice that includes a first locking element that exerts pressure viathe pressure element onto the head and the second locking element thatexerts pressure only onto the rod to lock the head and the rodindependently, may also be used. In some embodiments, the inner surfaceportion of the locking element that contacts the head (as in the firstembodiment) may not necessarily be spherically-shaped. The inner surfaceportion may have any other shape that is suitable to exert pressure ontothe head. Also, the design of the locking element can be different andis not limited to the specific design shown in the first or secondembodiments.

Instead of the pin for retaining the pressure element and for aligningthe pressure element with respect to the channel for receiving the rodof the receiving part, other retaining mechanisms can be used.

In the above embodiments, the accommodation space is of a substantiallycylindrical shape. However, other shapes or deviations from acylindrical may be possible as well which allow a locking element(having corresponding shapes or deviations) to move between therespective first and second positions connected with the unlocked andlocked states.

In the above embodiments, the locking element is shown as either beingprovided with arms and shoulders to effect a pre-locked state or withoutarms. However, both embodiments may also be formed without arms, or witharms, and with corresponding functions, respectively.

The coupling assembly of the above or further embodiments including theretainer and the locking element (embodied as a pressure element or not)may be in situ snapped-on to the head 3, 3′ of anchoring element 1, 1′when the anchoring element is inserted into a bone, e.g., a vertebra, orin a not yet implanted state.

While the present invention has been described in connection withcertain exemplary embodiments, it is to be understood that the inventionis not limited to the disclosed embodiments, but is instead intended tocover various modifications and equivalent arrangements included withinthe spirit and scope of the appended claims, and equivalents thereof.

1. A coupling assembly for coupling a rod to a bone anchoring element,the coupling assembly comprising: a receiving part having a first end, asecond end, a central axis extending through the first end and secondend, an accommodation space for accommodating a head of an anchoringelement, the accommodation space having an opening at the second endsized so as to permit the insertion of a head and a bore extending fromthe accommodation space to the first end, and a recess for receiving arod, a retainer element configured to be positioned at least partiallyin the accommodation space and being radially expandable and/orcompressible so as to allow retaining a head which is inserted throughthe opening; a locking element, which is configured to be arranged atleast partially in the accommodation space, the locking element beingmovable from a first position, in which the retainer element is allowedto expand and release an inserted head, to a second position, in whichradial expansion of the retainer element is hindered so as to preventrelease of an inserted head; wherein, when the locking element is in thesecond position, a head of an anchoring element can be locked byexertion of a pressure force onto the head against the retainer element.2. The coupling assembly of claim 1, wherein the retainer elementdefines an open or closed ring-shape.
 3. The coupling assembly of claim1, wherein the retainer element includes one or more slits in order toallow the retainer element to be expanded and/or compressed. 4-8.(canceled)
 9. The coupling assembly of claim 1, wherein the retainerelement further includes a hollow spherical segment-shaped portionconfigured to receive the head therein.
 10. The coupling assembly ofclaim 1, wherein the locking element comprises an outer at leastpartially cylindrical surface dimensioned to be in sliding engagementwith an inner wall of the accommodation space when being receivedtherein at least between the first and second positions.
 11. Thecoupling assembly of claim 10, wherein the locking element is a pressureelement which is arranged to receive and transfer a pressure force froma fixation element which is attached to the bore of the receiving partat the first end, and/or a rod which is received in the recess of thereceiving part, towards the head in order to tight lock the head. 12.The coupling assembly of claim 11, wherein the inner cavity of thelocking element further comprises an inner hollow sphericalsegment-shaped recess configured to receive the head.
 13. The couplingassembly of claim 1, wherein the locking element comprises a rodreceiving portion configured to receive a rod.
 14. The coupling assemblyof claim 1, wherein the locking element comprises a first engagementshoulder configured to engage a second engagement shoulder provided inthe bore or accommodation space when the locking element is in thesecond position.
 15. The coupling assembly of claim 1, wherein theretainer element and/or the locking element are configured such as to beinsertable into the bore and accommodation space of the receiving partfrom the first end.
 16. A polyaxial bone anchoring device comprising abone anchoring element having a shank for anchoring to bone and a head,and the coupling assembly of claim
 1. 17. (canceled)